Chronic Hepatitis b
Conditions
Brief summary
This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients from 18 to 65 years of age; 2. Chronic hepatitis B infection 3. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug; 4. Agree to participate in the study and sign the patient informed consent.
Exclusion criteria
1. Patients who had NAs resistance; 2. Other antiviral, anti-neoplastic or immunomodulatory treatment; 3. Women with ongoing pregnancy or breast-feeding; 4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV); 5. ALT \>10 ULN; 6. LSM \>9kPa ; 7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia); 8. Signs or symptoms of hepatocellular carcinoma; 9. Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening; 10. Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men; 11. Serum creatinine level \> 1.5 ULN in screening period. 12. Phosphorus \< 0.65 mmol/L; 13. ANA \> 1:100; 14. History of severe psychiatric disease; 15. History of a severe seizure disorder or current anticonvulsant use; 16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.); 17. History of chronic pulmonary disease associated with functional limitation; 18. Diseases that IFN and Nucleotides or nucleosides are not suitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HBsAg quantification at week 24 | week 24 | HBsAg quantification are measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg loss rates at week 24 | week 24 | HBsAg loss rates are measured |
| HBsAg seroconversion rates at week 24 | week 24 | HBsAg seroconversion rates are measured |
| HBeAg loss rates at week 24 | week 24 | HBeAg loss rates are measured |
| HBeAg seroconversion rates at week 24 | week 24 | HBeAg seroconversion rates are measured |
| HBV DNA<20IU/mL rates at week 24 | week 24 | HBV DNA\<20IU/mL rates are measured |
Outcome results
None listed